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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a quasi-experimental study to evaluate your digital health product.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Find out who can get a free rapid lateral flow test, how to use the test and what your test result means.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Protocols and procedures for testing the value for cultivation or use (VCU) of agricultural crops.
Actions that trial sponsors should consider to build resilience into clinical trial design
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
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